FDA.reportPublic FDA data

Kryo

Primary DI
B199GDMR75000
Brand
Kryo
Company
PLANER LIMITED
Model
MR7-500
Catalog number
GDMR7-500
Device description
MR7 Controller for Kryo 560 & 570 Freezers
Published
2023-04-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
KSPApparatus, Cell-Freezing And Reagents

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KSPApparatus, Cell-Freezing And ReagentsHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B199GDMR75000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Freezer control unit, programmableA mains electricity (AC-powered) unit used together with a specific freezer where it is important that a certain predetermined freezing pattern is followed in order to preserve the contents of the freezer. This pattern may differ according to various considerations, e.g., lowering of temperature by steps over a given time. A pre-set program will be imposed upon the freezer.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
217190495
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B199GDKRYO3701150KryoGDKRYO370-1152024-10-22
B199GDKRYO370CH1150KryoGDKRYO370-CH-1152024-10-22
B199GDKRYO5701150KryoGDKRYO570-1152024-10-22
B199GDKRYO570ART1150KryoGDKRYO570ART-1152024-10-22
B199GDKRYO570ARTCH1150KryoGDKRYO570ART-CH-1152024-10-22
B199GDKRYO570CH1150KryoGDKRYO570-CH-1152024-10-22
B199GDKRYO36017115020KryoKRYO360-1.7-115-02GDKRYO360-1.7-115-022023-04-30
B199GDKRYO36033115020KryoKryo360-3.3-115-02GDKRYO360-3.3-115-022023-04-30
B199GDKRYO56016115020KryoKRYO560-16-115-02GDKRYO560-16-115-022023-04-30
B199GDMR75600KryoMR7-560GDMR7-5602023-04-30
B199GDMR70MR7 ControllerGDMR72022-02-28
B199GDBT3702CS0BT37BT37-02GDBT37-02-CS2020-07-01
B199GDBT3702WWCS0BT37BT37-02GDBT37-02-WW-CS2020-07-01
B199GDBT3701ORIGIO0BT37 IncubatorGDBT37-01-ORIGIO2016-09-23
B199GDBT37USORIGIO0BT37 IncubatorGDBT37-US-ORIGIO2016-09-23
B199GDBT37WWORIGIO0BT37 Incubator GDBT37-WW-ORIGIO2016-09-23
B199GDCT37M0CT37 IncubatorGDCT37-M2018-04-03
B199GDCT37M30CT37 IncubatorGDCT37-M-3 2018-04-03
B199GDCT37M3CO20CT37 IncubatorGDCT37-M-3-CO22018-04-03
B199GDCT37M40CT37 IncubatorGDCT37-M-4 2018-04-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B199GDKRYO3701150KryoPLANER LIMITEDKSP2024-10-22
B199GDKRYO370CH1150KryoPLANER LIMITEDKSP2024-10-22
B199GDKRYO5701150KryoPLANER LIMITEDKSP2024-10-22
B199GDKRYO570ART1150KryoPLANER LIMITEDKSP2024-10-22
B199GDKRYO570ARTCH1150KryoPLANER LIMITEDKSP2024-10-22
B199GDKRYO570CH1150KryoPLANER LIMITEDKSP2024-10-22
B199GDKRYO36017115020KryoPLANER LIMITEDKSP2023-04-30
B199GDKRYO36033115020KryoPLANER LIMITEDKSP2023-04-30
B199GDKRYO56016115020KryoPLANER LIMITEDKSP2023-04-30
B199GDMR75600KryoPLANER LIMITEDKSP2023-04-30
B199GDMR70MR7 ControllerPLANER LIMITEDKSP2022-02-28
B199GDKRYO360171150Kryo 360 FreezerPLANER LIMITEDKSP2016-09-23
B199GDKRYO36017115DT0Kryo 360 FreezerPLANER LIMITEDKSP2016-09-23
B199GDKRYO360331150Kryo 360 FreezerPLANER LIMITEDKSP2016-09-23
B199GDKRYO36033115DT0Kryo 360 FreezerPLANER LIMITEDKSP2016-09-23
B199GDKRYO560161150Kryo 560 FreezerPLANER LIMITEDKSP2016-09-23
B199GDKRYO56016155DT0Kryo 560 FreezerPLANER LIMITEDKSP2016-09-23
B199GDKRYO750PLUSF1150Kryo 750 Freezer - Front LoaderPLANER LIMITEDKSP2016-09-23
B199GDKRYO750PLUST1150Kryo 750 Freezer - Top LoaderPLANER LIMITEDKSP2016-09-23
B199GDMRV0MRV ControllerPLANER LIMITEDKSP2016-09-23
B199GDMRVADAPTOR0MRV Controller AdaptorPLANER LIMITEDKSP2016-09-23
B199GDMRVADAPTORM0MRV Controller AdaptorPLANER LIMITEDKSP2016-09-23
B199GDMRVM0MRV ContollerPLANER LIMITEDKSP2016-09-23